Pegasys VR: Integrating Virtual Humans in the Treatment of Child Social Anxiety



Status:Completed
Conditions:Anxiety
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:7 - 12
Updated:10/21/2018
Start Date:June 2016
End Date:August 2018

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Among children, social anxiety is a common, severe and chronic disorder. Social Effectiveness
Therapy for Children (SET-C) is an empirically supported treatment with significant potential
to impact the lives of children with this severe and chronic disorder. The proposed
Pegasys-VR™ system will distinctly enhance its utility, as it will allow dissemination to a
broad variety of clinical settings including schools as well as traditional outpatient
clinics. Its use for the treatment of social skills deficits will offer a superior solution
for mental health personnel, solving many of the resource and logistic barriers that they
currently face. The final product will address cost and practical issues by disseminating an
empirically-supported treatment that was rigorously built and tested. Using VE will make the
traditional social skills therapy programs program cost-effective and patient-centric,
allowing even clinicians with little background/training in behavior therapy to have tools
not typically available to them.

Anxiety disorders are the most common psychiatric disorders among youth, with lifetime
prevalence ranging between 18-20% of the general population. Among anxiety disorders, social
anxiety disorder (SAD) affects 8% of all youth, resulting in significant short and long-term
impairment, including increased likelihood of substance abuse, limited academic achievement,
attenuated occupational functioning, and impaired or missing social relationships. Emerging
data suggest that interventions that include social skills training, formal peer
generalization sessions, and homework assignments as part of an overall treatment strategy
show enhanced efficacy when compared to interventions without these components - the latter
two elements which are designed to enhance skill generalization. Two critical treatment
elements (peer generalization, homework assignments) are difficult to implement in
traditional clinical settings, limiting optimal dissemination to youth in need of these
services in different settings (e.g., at school, outpatient, or community facilities). In a
recently completed Phase I STTR, the investigators developed and validated an interactive
virtual environment (VE) to solve the need for intensive behavioral practice opportunities
that are critical for skill generalization. The VE, known as Pegasys-VR™, allowed intensive
practice of social skills without the need for formal peer group activities (in clinic
solution) or intensive parental involvement (at-home solution). The results indicated that
implementing a VE environment into the SET-C program was accessible, credible and feasible
for the parents, clinicians and children who participated in the trial. Furthermore,
examination of within group changes indicated statistically significant improvement in SAD
symptoms. Given the success of the Phase I, and the need to increase the automation of the
system to increase its acceptance and adoption among clinicians and socially anxiety youth,
the Phase II STTR study will have the following goals: incorporate an artificial intelligence
natural language system, develop additional VEs for in-clinic practice, expand the homework
solution to provide additional opportunities to reinforce skills acquisition and
generalization practice in in-vivo settings, using serious game theory and technology, and
conduct a randomized controlled trial with youth ages 7 to 12 to test whether Pegasys-VR™ is
as effective as a traditional behavioral interventions for youth with social anxiety disorder
and if the effects are maintained at 3 month follow-up. If Pegasys-VR™ is clinically
efficacious, it would offer a sustainable, cost-effective intervention that can be easily and
rapidly disseminated.

Inclusion Criteria:

- Diagnosis of social anxiety disorder

Exclusion Criteria:

- an IQ < 85 and/or the presence of comorbid conduct disorder, bipolar disorder, severe
depression, suicidal ideation, ADHD, developmental disorders or psychotic disorders
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